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Introduction About EVAFIL TABLET

EVAFIL TABLET contains Estradiol which belongs to the group of medicines called Estrogens. EVAFIL TABLET is used in postmenopausal women (with at least 6 months since their last natural period) to provide relief from symptoms that occurs after menopause. It is also used to manage osteoporosis (condition marked by weak and fragile bones) which occurs after menopause in few women.

EVAFIL TABLET is not recommended for use in patients allergic to Estradiol. It is also not recommended for use in patients who have/had/suspected of breast/endometrial cancer or thrombosis (blood clot in vein). The medicine is also not indicated for use in patients who suffer from unusual vaginal bleeding, unmanageed endometrial hyperplasia (excessive thickening of the womb lining), lung disease (such as pulmonary embolism), heart disease (such as heart attack/heart block), and/or liver disease (such as benign liver tumour).

Before taking EVAFIL TABLET, inform your doctor if you have fibroids (non-cancerous growths inside womb), endometriosis (growth of womb lining outside womb)/endometrial hyperplasia (excessive growth of the womb lining), and/or suffer from epilepsy, otosclerosis (disease that affects eardrum and hearing), kidney problems, and/or lung problems (such as asthma).

EVAFIL TABLET is not recommended for use in pregnant and breast-feeding women since it is intended to be used only in postmenopausal women. The medicine is also not recommended for use in children and adolescents since it is indicated for use only in postmenopausal women. It is advised to be used with caution in elderly women (aged 60 years and above) after consulting the doctor since the medicine may increase the risk of heart disease in elderly patients.

The common side effects of taking EVAFIL TABLET are headache, nausea, cramps in legs, abdominal/pelvic pain, unscheduled bleeding/spotting, asthenia (feeling of weakness), and/or rash/itching. Consult your doctor if any of these symptoms worsens.

Uses Of EVAFIL TABLET

Provides relief from symptoms that occur after menopause in postmenopausal women
Prevents osteoporosis in post-menopausal women

How EVAFIL TABLET Works

EVAFIL TABLET contains precursor of ovarian hormones (responsible for menstruation and reproduction in women) which replaces natural Estradiol hormone in the body that helps in maintaining adequate level of circulating hormones thus providing relief from vasomotor symptoms (such as hot flashes) in post-menopausal women.

How to use EVAFIL TABLET

Take EVAFIL TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

Side Effects Of EVAFIL TABLET

Common

headache
nausea
cramps in legs
abdominal/pelvic pain
unscheduled bleeding/spotting
asthenia (feeling of weakness)
changes in weight
rash/itching

Uncommon

signs of hypersensitivity (allergic) reaction such as skin rash, itch, and/or skin redness
red itchy welts
painful red nodules of skin (erythema nodosum)
feeling down
vaginal thrush (fungal infection in vagina caused by Candida albicans)
high blood pressure
peripheral oedema (swelling of ankles, feet/fingers)
oedema (water retention)
varicose veins (twisted/enlarged veins)
back pain
indigestion
nervousness
dizziness
problems with sight
fast heart beats
breast pain/tenderness

Rare

intolerance to contact lenses
pre-menstrual tension (PMT)
feeling anxious
migraine
vomiting
bloating
excessive hair growth
acne
muscle cramps
vaginal discharge
tiredness
swelling of breasts
change in sex drive

Stop taking EVAFIL TABLET and consult your doctor immediately if you experience any of the following:

suspected of breast cancer/endometrial cancer
unexplained vaginal bleeding
signs of endometrial hyperplasia (excessive thickening of the womb lining) such as heavy menstrual bleeding, anaemia, bleeding between menstrual periods
thrombosis (blood clot in a vein) such as deep venous thrombosis
signs of blood clot such as painful swelling & redness of the legs, sudden chest pain, and/or difficulty in breathing
signs of liver disease such as yellowing of skin or whites of eyes (jaundice)
signs of angioedema such as swollen face/tongue/throat, difficulty while swallowing, red itchy welts, and/or difficulty breathing
signs of high blood pressure such as headache, tiredness, and/or dizziness
migraine-like headaches (happening for the first time)
heart attack
heavy, irregular/painful bleeds

How To Manage Side Effects

Headache:

If EVAFIL TABLET causes headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of taking EVAFIL TABLET. If it lasts more than a week or becomes severe, then consult and inform your doctor.

Nausea/vomiting:

Take EVAFIL TABLET with/just after a meal. Stick to simple meals. Avoid eating oil rich/spicy foods, sugary snacks and drinks. Avoid drinking too much liquid along with your meals, and drink slowly in between meals. Consult your doctor if the condition worsens.

Rashes:

Do not scratch the affected area. Wear protective clothing while going outdoors. Regularly moisturize your skin. Consult and inform your doctor if the symptom gets worse.

Itchy Skin:

Try to pat or tap your skin instead of scratching it. Hold a damp towel to cool your skin. Wear loose clothing and avoid tight clothes, or clothes made from wool or synthetic fabrics. Avoid using perfumed soaps, deodorants or moisturizers and use a skin softener regularly.

Indigestion:

Try to have smaller and more frequent meals and drink slowly. Reduce consumption of coffee, cola, tea, or alcohol and lose weight if you are obese. Try to avoid smoking and don’t have rich, fatty or spicy foods. Consult your doctor and inform if the symptom does not improve.

Tiredness:

Make sure you take rest and drink plenty of fluids. Avoid or limit the consumption of alcohol. Try to take EVAFIL TABLET at a time when you can sit down (or lie down) when the symptoms are at their worst. Avoid driving or using tools or machinery until you feel well.

Warning & Precautions

Pregnancy

EVAFIL TABLET is not recommended for use during pregnancy and in women planning for pregnancy since it is intended to be used only in postmenopausal women. Consult your doctor before taking the medicine and stop the medicine immediately if you become pregnant or think you may be pregnant.

Breastfeeding

EVAFIL TABLET is not recommended for use in breastfeeding women as it is intended to be used only in postmenopausal women. Consult your doctor before taking EVAFIL TABLET.

Kidney

EVAFIL TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking EVAFIL TABLET.

Liver

EVAFIL TABLET is not recommended for use in patients with/history of liver disease (such as benign liver tumour) and in patients who have abnormal liver function. Consult your doctor before taking EVAFIL TABLET.

Allergy

Do not take EVAFIL TABLET if you are allergic (hypersensitive) to Estradiol, and/or any other ingredients of this medicine.

Lungs

EVAFIL TABLET is not recommended for use in patients with lung disease such as pulmonary embolism (blood clot in lungs). It should be used with caution in patient with other lung problems such as asthma. Consult your doctor before taking EVAFIL TABLET.

Heart Disease

EVAFIL TABLET is not recommended for use in patients with heart disease such as heart attack/heart block. Consult your doctor before taking the medicine.

Others

EVAFIL TABLET is not recommended for use if you:

have/had/suspected of breast cancer
have/suspected of endometrium cancer
have unusual vaginal bleeding
suffer from unmanageed endometrial hyperplasia (excessive thickening of the womb lining)
have/had thrombosis (blood clot in a vein) such as deep venous thrombosis
have blood clotting disorder such as protein C/protein S/antithrombin deficiency
have/recently had blood clots in arteries such as stroke
suffer from inherited porphyria (rare blood disorder)

Before taking EVAFIL TABLET, inform your doctor if you:

have fibroids (non-cancerous growths) inside womb
suffer from endometriosis (growth of womb lining outside womb) or have a history of endometrial hyperplasia (excessive growth of the womb lining)
have an increased risk of developing blood clots
have an increased risk of developing estrogen-sensitive cancer such as mother, sister/ grandmother who has/had breast cancer
suffer from high blood pressure, diabetes, gallstones, migraine/severe headaches
suffer from systemic lupus erythematosus (disease of the immune system that affects many organs of the body)
suffer from epilepsy
suffer from otosclerosis (disease affecting eardrum and hearing), hereditary and acquired angioedema
are scheduled for any surgery

Use in Paediatrics:

EVAFIL TABLET is not recommended for use in children and adolescents since it is intended to be used only in postmenopausal women.

Use in Geriatrics:

EVAFIL TABLET should be used with caution in elderly women (aged 60 years and above) due to increased risk of developing heart disease. Consult your doctor before taking EVAFIL TABLET.

Interactions

A. Drug-Drug Interactions:

Before taking EVAFIL TABLET, inform your doctor if you are taking any of the following medicine:

medicines used to manage blood clotting (Ex. warfarin)
medicines used to manage epilepsy (Ex. phenobarbital, phenytoin, carbamazepine)
medicines used to manage tuberculosis (Ex. rifampicin, rifabutin)
anti-retroviral medicines used to manage HIV (Ex. nevirapine, efavirenz, ritonavir, nelfinavir)
St John’s Wort (herbal medicine used to manage depression)
medicines used to manage Hepatitis C Virus (Ex. boceprevir, telaprevir)
tacrolimus, cyclosporin (medicines used to manage rejection of organ transplants)
fentanyl (used to reduce pain)
theophylline (used for asthma and other breathing problems)

Overdosage:

If you or anyone else accidentally takes too much of EVAFIL TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are nausea, vomiting, sleepiness, dizziness, and/or withdrawal bleeding.

Synopsis

Drug	:	Estradiol
Pharmacological Category	:	Estrogens
Therapeutic Indication	:	Provides relief from symptoms after menopause, Prevents osteoporosis (after menopause)
Dosage Forms	:	Tablet, Cream, Gel, Transdermal Patch

More Information

Keep EVAFIL TABLET out of reach of children
Store EVAFIL TABLET at room temperature

FAQs About EVAFIL TABLET

Q. What is EVAFIL TABLET used for?

A. EVAFIL TABLET is used in postmenopausal women (with at least 6 months since their last natural period) to provide relief from symptoms that occurs after menopause. It is also used to manage osteoporosis (condition marked by weak and fragile bones) which occurs after menopause in few women.

Q. What are the common side effects of taking EVAFIL TABLET?

A. The most common side effects of taking EVAFIL TABLET are headache, nausea, cramps in legs, abdominal/pelvic pain, unscheduled bleeding/spotting, asthenia (feeling of weakness), and/or rash/itching. Consult your doctor if any of these symptoms worsens.

Q. How EVAFIL TABLET is taken?

A. Take EVAFIL TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

Q. What happens if EVAFIL TABLET is taken more than its required dosage?

A. If you or anyone else accidentally takes too much of EVAFIL TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are nausea, vomiting, sleepiness, dizziness, and/or withdrawal bleeding.

Q. How EVAFIL TABLET works?

A. EVAFIL TABLET contains precursor of ovarian hormones (responsible for menstruation and reproduction in women) which replaces natural Estradiol hormone in the body that helps in maintaining adequate level of circulating hormones thus providing relief from vasomotor symptoms (such as hot flashes) in post-menopausal women.

References

1. K.D. Tripathi. Estrogens, Progestins and Contraceptives. Essentials of Medical Pharmacology. seventh edition. 2013. Page – 306.

2. Nosek, M., Kennedy, H.P. and Gudmundsdottir, M. Distress during the menopause transition: a rich contextual analysis of midlife women’s narratives. Sage Open. 2012. [Accessed on 6th July 2022] https://journals.sagepub.com/doi/pdf/10.1177/2158244012455178#:~:text=The%20women%20reported%20a%20range,%3B%20see%20also%20Table%201)

3. Estradiol. NIH National Library of Medicine. National center for biotechnology information. PubChem. July 2022. [Accessed on 6th July 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Estradiol

4. Cipla Ltd. Estova Tablet. [Revised in February 2021] [Accessed on 6th July 2022] https://www.ciplamed.com/content/estova-tablets

5. TTK Healthcare Limited. Primiwal Tablet. [Revised in February 2021] [Accessed on 6th July 2022] https://ttkhealthcare.com/ethical-products/

6. Abbott Biologicals BV. Electronic Medicines Compendium (EMC) [Revised in March 2022] [Accessed on 6th July 2022] https://www.medicines.org.uk/emc/files/pil.1174.pdf

Useful Diagnostic Tests

Liver Function Test (LFT)

Author Details

Written By Dr. K .AZEEM HUSSAIN - B.D.S

Reviewed For Accuracy By Dr. Jaya Prabakaran - MBBS, MD (Diabetology and Family Medicine)

Last updated on 11 Jan 2023 | 06:53 PM(IST)